PROs and Data Collection

Instruments that create data in a digital format are a usual source of information that gets directly linked to the study database. This sounds attractive but such connection must also follow strict rules and may be difficult to achieve. For example, when different laboratories are involved, they all have to adhere to the same data entry standards, normal ranges of their analytical methods, etc.

Some examples of direct data capture (DDC) are:

• Laboratory data – generated either by central or local labs.
  
• Electrocardiogram data (ECG).
  
• Central image reading – e.g. Magnetic Resonance Imaging (MRI) results.
  
• Electronic patient questionnaires / diaries.
  

More recently, mobile apps can provide data by monitoring for example physical activity or quality of sleep.